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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; TRANSMITTER
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NIHON KOHDEN CORPORATION; TRANSMITTER Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 11/23/2019
Event Type  Death  
Manufacturer Narrative
The director of is and clinical engineering reported that a patient expired while being monitored on an nk telemetry transmitter.That is all the information that was received from them as they are still investigating this issue internally.Attempts have been made to get additional description of event and patient details with no response as of yet.It is unclear if the device malfunctioned and no device model or serial number information was provided.However, as there has been a patient death reported to us, we are reporting this complaint to err on the side of caution.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.The following fields contain no information (ni), as attempts to obtain information were made, but not provided.Date of patient death.Model number, catalog number, serial number, unique identifier (udi) number approximate age of device.No model/serial provided so age of device is not known.Pma/510(k) number.No model provided so 510k is not known.Device manufacturer date.No model / serial number was provided and unable to determine device manufacturer date.
 
Event Description
The director of is and clinical engineering reported that a patient expired while being monitored on an nk telemetry transmitter.That is all the information that was received from them as they are still investigating this issue internally.Attempts have been made to get additional description of event and patient details with no response as of yet.It is unclear if the device malfunctioned and no device model or serial number information was provided.However, as there has been a patient death reported to us, we are reporting this complaint to err on the side of caution.
 
Manufacturer Narrative
Details of complaint: on (b)(6) 2019, customer at (b)(6) reported a patient passed while being monitored on an nk telemetry device.Investigation conclusion: it is not known whether an nk device malfunction or deficiency may have contributed to the patient event.Attempts were made to obtain additional information regarding the event along with information of the device involved however no further information have been provided.Due to the lack of information available, no root cause analysis or risk assessment could be performed.
 
Event Description
The director of is and clinical engineering reported that a patient expired while being monitored on an nk telemetry transmitter.That is all the information that was received from them as they are still investigating this issue internally.Attempts have been made to get additional description of event and patient details with no response as of yet.It is unclear if the device malfunctioned and no device model or serial number information was provided.However, as there has been a patient death reported to us, we are reporting this complaint to err on the side of caution.
 
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Brand Name
NI
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 161-8 560
JA  161-8560
MDR Report Key9501066
MDR Text Key172184629
Report Number8030229-2019-00737
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/25/2020
Distributor Facility Aware Date02/24/2020
Event Location Hospital
Date Report to Manufacturer02/25/2020
Initial Date Manufacturer Received 11/25/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received02/24/2020
Supplement Dates FDA Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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